Siemens SOMATOM Sensation 64 CT Scanner Recalled for Incorrect Dose Calculations
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 64 CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unnecessary radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Sensation 64 CT scanner. The device is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall was initiated to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on posterior-anterior (p.a.) or anterior-posterior (a.p.) topograms.
The issue arises from the geometrical shape of the skull bone. In rare cases, the calculated dose distribution may be inappropriate, which could lead to unnecessary radiation exposure to the patient. The affected units were distributed nationally in the United States.
Customers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and any necessary corrective actions for the affected devices.
The recalled product
- Product
- SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 1,301
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 8377520
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · radiation exposure
See all →- HighPhilips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
- HighPhilips Allura Xper hand switch buttons may not fully release
FDA (Devices) · 2026-06-24
- HighPhilips MultiDiagnost Eleva hand switch buttons may not fully release
FDA (Devices) · 2026-06-24